MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ENO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number ENO DR

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

On (b)(6) 2024, 2 days post implantation, the ventricular lead impedance was found > 3000 ohms.A reintervention was performed on the same day and the physician has found that the ventricular lead was disconnected from its connector port and the setscrew could not be screwed.There was no consequence on the patient.

Event Description

On (b)(6) 2024, 2 days post implantation, the ventricular lead impedance was found > 3000 ohms.A reintervention was performed on the same day and the physician has found that the ventricular lead was disconnected from its connector port and the setscrew could not be screwed.There was no consequence on the patient.

Manufacturer Narrative

The conclusions are as follows: - the electrical characteristics of the returned device conformed to established specifications.Upon reception of the device, pacing pulses were generated appropriately by the device.- the visual inspection did not reveal any abnormality.The analysis confirms that the connection system of the subject pacemaker functioned as specified using a duplicate torque-limiting screwdriver.- presence of blood inside the ventricular silicone cap was found, as well as, inside the ventricular setscrew cavity.Blood introduction could have occurred during the lead connection.This may have been incurred through repetitive insertion and removal of the associated screwdriver and/or blood infiltration during the device implantation prior the lead insertion generating a few days later blood clots.Those blood clots could be an obstacle for a correct lead connection.- based on the available data, no issue is suspected on the subject pacemaker.- the complaint is recorded for trending purposes.

• Brand Name: ENO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 18822956
• MDR Text Key: 337652648
• Report Number: 1000165971-2024-00199
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(17)190925(11)190923
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENO DR
• Device Catalogue Number: TPM014C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic